Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia

Dyslipidemia Clinical Trial

Official title:

Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019263
• Other study ID #: 20140012470
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 12, 2018
• Start date: March 31, 2017
• Est. completion date: January 12, 2018

Study information

• Verified date: January 2018
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Menopause is usually associated with an increase in body weight, a change in body composition and fat distribution and a large number of cardio-metabolic changes, such as hypertension, reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these complications is the modification of dietary habits and lifestyle in terms of physical activity. Besides, there is also a growing interest in complementary therapies (i.e. nutraceuticals) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of their use, the evidence from good quality trials is limited.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• LDL cholesterol >100 mg/dL

• Written informed consent available

Exclusion Criteria:

• Use of any drug affecting blood lipids

• Hormone replacement therapy

• Adherence to a weigh loss diet in the previous 6 months

• Cancer diagnosis

• Known thyroid, liver, renal or muscle diseases

• Any medical or surgical condition which could lead to an inconstant adhesion to the protocol

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Dietary Supplement:
• Nutraceutical
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid

Other:
• Control
Nutritional counseling

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo	University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol	LDL cholesterol	3 months
Secondary	Insulin resistance	Homeostatic model assessment (HOMA index)	3 months
Secondary	Total cholesterol	Total cholesterol	3 months
Secondary	HDL cholesterol	HDL cholesterol	3 months
Secondary	Blood glucose	Blood glucose	3 months
Secondary	Serum Insulin	Serum Insulin	3 months
Secondary	Body weight	Body weight	3 months
Secondary	Fat distribution	Waist circumference	3 months
Secondary	Fat Mass	Fat Mass	3 months
Secondary	Menopausal symptoms	Greene Climacteric Scale	3 months
Secondary	Quality of life	36-Item Short Form Health Survey (SF-36)	3 months